Interpace Biosciences Announces New PLA Code and Medicare Reimbursement Increase for Proprietary Thyroid Assay, ThyGeNEXT®
April 05 2021 - 3:05PM
Interpace Biosciences, Inc. (“Interpace” or the “Company”)
(OTCQX: IDXG) announced today that Novitas, its Medicare
Administrative Contractor, has agreed to recognize the new
Proprietary Laboratory Analysis (PLA) code that specifically
identifies ThyGeNEXT® as a distinct test from any other test or
service. PLA codes are an addition to the current procedural
terminology (CPT®) code set approved by the American Medical
Association CPT® Editorial Panel. PLA codes are alpha-numeric
CPT codes with a corresponding descriptor for labs that want to
more specifically identify their test. The new PLA code for
ThyGeNEXT® is 0245U and the reimbursement for this code remains
$2,919, representing a significant price increase over the prior
reimbursement level of $560. In December, 2020, Novitas issued a
new local coverage determination (LCD) for ThyGeNEXT® that reflects
the test’s enhanced mutation panel. In 2020, Interpace processed
approximately 15,000 ThyGeNEXT® tests for over 700 physicians.
Further information regarding the billing and
coding article related to this change is available on the Centers
for Medicare & Medicaid Services (CMS) website under Biomarkers
for Oncology (A52986). The change to the code will be officially
published on-line when Novitas updates their website April 22nd,
2021.
According to Tom Burnell, President & CEO of
Interpace, “This is an important milestone for our Company; it not
only demonstrates the enhanced value that ThyGeNEXT® provides
physicians and their patients, but recognizes the enhancements made
to the assay since it was first developed and launched.” He
continued “This newly established code will also provide
incremental financial value to the Company as we roll out the new
code and its associated fee.” About ThyGeNEXT®
and ThyraMIR®
ThyGeNEXT® utilizes state-of-the-art
next-generation sequencing (NGS) to identify more than 100 genetic
alterations associated with papillary and follicular thyroid
carcinomas, the two most common forms of thyroid cancer, as well as
Medullary Thyroid Carcinoma. ThyraMIR® is the first microRNA gene
expression classifier. MicroRNAs are small, non-coding RNAs that
bind to messenger RNA and regulate expression of genes involved in
human cancers, including every subtype of thyroid cancer. ThyraMIR®
measures the expression of 10 microRNAs. Both ThyGeNEXT® and
ThyraMIR® are covered by Medicare and Commercial insurers, with
more than 280 million members covered.
According to the American Thyroid Association,
approximately 20% of the 525,000 thyroid fine needle aspirations
(FNAs) performed on an annual basis in the U.S. are indeterminate
for malignancy based on standard cytological evaluation, and thus
are candidates for ThyGeNEXT® and ThyraMIR®.
ThyGeNEXT® and ThyraMIR® reflex testing yields
high predictive value in determining the presence and absence of
cancer in thyroid nodules. The combination of both tests can
improve risk stratification and surgical decision-making when
standard cytopathology does not provide a clear diagnosis.
About Interpace Biosciences
Interpace Biosciences is an emerging leader in
enabling personalized medicine, offering specialized services along
the therapeutic value chain from early diagnosis and prognostic
planning to targeted therapeutic applications.
Clinical services, through Interpace
Diagnostics, provides clinically useful molecular diagnostic tests,
bioinformatics and pathology services for evaluating risk of cancer
by leveraging the latest technology in personalized medicine for
improved patient diagnosis and management. Interpace has five
commercialized molecular tests and one test in a clinical
evaluation process (CEP): PancraGEN® for the diagnosis and
prognosis of pancreatic cancer from pancreatic cysts; PanDNA, a
“molecular only” version of PancraGEN® that provides physicians a
snapshot of a limited number of factors; ThyGeNEXT® for the
diagnosis of thyroid cancer from thyroid nodules utilizing a next
generation sequencing assay; ThyraMIR® for the diagnosis of thyroid
cancer from thyroid nodules utilizing a proprietary gene expression
assay; and RespriDX® that differentiates lung cancer of primary
versus metastatic origin. In addition, BarreGEN®, a molecular based
assay that helps resolve the risk of progression of Barrett’s
Esophagus to esophageal cancer, is currently in a clinical
evaluation program (CEP) whereby we gather information from
physicians using BarreGEN® to assist us in gathering clinical
evidence relative to the safety and performance of the test and
also providing data that will potentially support payer
reimbursement.
Pharma services, through Interpace Pharma
Solutions, provides pharmacogenomics testing, genotyping,
biorepository and other customized services to the pharmaceutical
and biotech industries. Pharma services also advances personalized
medicine by partnering with pharmaceutical, academic, and
technology leaders to effectively integrate pharmacogenomics into
their drug development and clinical trial programs with the goals
of delivering safer, more effective drugs to market more quickly,
while also improving patient care.
For more information, please visit Interpace Biosciences’
website at www.interpace.com.
Forward-looking Statements
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, relating to the
Company’s future financial and operating performance. The Company
has attempted to identify forward looking statements by terminology
including “believes,” “estimates,” “anticipates,” “expects,”
“plans,” “projects,” “intends,” “potential,” “may,” “could,”
“might,” “will,” “should,” “approximately” or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are based on current
expectations, assumptions and uncertainties involving judgments
about, among other things, future economic, competitive and market
conditions and future business decisions, all of which are
difficult or impossible to predict accurately and many of which are
beyond the Company’s control. These statements also involve known
and unknown risks, uncertainties and other factors that may cause
the Company’s actual results to be materially different from those
expressed or implied by any forward-looking statements including,
but not limited to, the adverse impact of the COVID-19 pandemic on
the Company’s operations and revenues, the substantial doubt about
the Company’s ability to continue as a going concern, the
possibility that the Company’s estimates of future revenue may
prove to be materially inaccurate, the Company’s history of
operating losses, the Company’s ability to adequately finance its
business, the Company’s ability to repay its $5M secured bridge
loan, the Company’s dependence on sales and reimbursements from its
clinical services, the Company’s ability to retain or secure
reimbursement including its reliance on third parties to process
and transmit claims to payers and the adverse impact of any delay,
data loss, or other disruption in processing or transmitting such
claims, the Company’s revenue recognition being based in part on
estimates for future collections which estimates may prove to be
incorrect, and the Company’s ability to remediate material
weaknesses in internal controls. Additionally, all forward-looking
statements are subject to the “Risk Factors” detailed from time to
time in the Company’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2020 to be filed with the Securities and
Exchange Commission , Current Reports on Form 8-K and Quarterly
Reports on Form 10-Q. Because of these and other risks,
uncertainties and assumptions, undue reliance should not be placed
on these forward-looking statements. In addition, these statements
speak only as of the date of this press release and, except as may
be required by law, the Company undertakes no obligation to revise
or update publicly any forward-looking statements for any
reason.
Contacts:Investor RelationsEdison GroupJoseph
Green/ Megan Paul(646)
653-7030/7034jgreen@edisongroup.com/mpaul@edisongroup.com
Interpace Biosciences (NASDAQ:IDXG)
Historical Stock Chart
From Apr 2024 to May 2024
Interpace Biosciences (NASDAQ:IDXG)
Historical Stock Chart
From May 2023 to May 2024